The New York Times reports (below) that The Institute of Medicine (IOM) panel–which includes a well known bioethicist–recommended lifting 1978 federal regulations restricting the use of prisoners in medical experiments.

What the Times didn’t tell readers is that the IOM is not the independent body of scientists it pretends. IOM members constitute an elite–members only association of physicians and academics who individually or throught their academic institutions have a significant financial stake in the pharmaceutical-biotech industry.

The panel voted shamelessly to recommend violating the Nuremberg Code (1947) and the federal restrictions (1978) on the proscription against the use of prisoners in medical experiments–because such experiments constitute an exploitation of prisoners who are precluded by their status from saying NO to high risk medical experiments.

In July 2005, at the invitation of the IOM committee I gave testimony on behalf of the Alliance for Human Research Protection about prison research at the panel’s meeting in San Francisco. I provided evidence of current–as opposed to historic–prison research abuse by the University of Texas and the University of California, SF. I pleaded against weakening federal restrictions from a moral position, recognizing that prisoners are human beings.

AHRP is committed to openness and full disclosure. We believe in accountability of those who influence public policy.As the Times reports (below) the recommendation is entirely commercially driven: “The discussion comes as the biomedical industry is facing a shortage of testing subjects.”

The INSTITUTE OF MEDICINE COMMITTEE ON ETHICAL CONSIDERATIONS FOR REVISIONS TODHHS REGULATIONS FOR PROTECTION OF PRISONERS INVOLVED IN RESEARCH

PHILADELPHIA, Aug. 7 — An influential federal panel of medical advisers hasrecommended that the government loosen regulations that severely limit thetesting of pharmaceuticals on prison inmates, a practice that was all butstopped three decades ago after revelations of abuse.

The proposed change includes provisions intended to prevent problems thatplagued earlier programs. Nevertheless, it has dredged up a painful historyof medical mistreatment and incited debate among prison rights advocates andresearchers about whether prisoners can truly make uncoerced decisions,given the environment they live in.

Supporters of such programs cite the possibility of benefit to prisonpopulations, and the potential for contributing to the greater good.

Until the early 1970’s, about 90 percent of all pharmaceutical products weretested on prison inmates, federal officials say. But such researchdiminished sharply in 1974 after revelations of abuse at prisons likeHolmesburg here, where inmates were paid hundreds of dollars a month to testitems as varied as dandruff treatments and dioxin, and where they wereexposed to radioactive, hallucinogenic and carcinogenic chemicals.

In addition to addressing the abuses at Holmesburg, the regulations were areaction to revelations in 1972 surrounding what the government called theTuskegee Study of Untreated Syphilis in the Negro Male, which was begun inthe 1930’s and lasted 40 years. In it, several hundred mostly illiterate menwith syphilis in rural Alabama were left untreated, even after a cure wasdiscovered, so that researchers could study the disease.

“What happened at Holmesburg was just as gruesome as Tuskegee, but atHolmesburg it happened smack dab in the middle of a major city, not in somebackwoods in Alabama,” said Allen M. Hornblum, an urban studies professor atTemple University and the author of “Acres of Skin,” a 1998 book about theHolmesburg research. “It just goes to show how prisons are truly distinctinstitutions where the walls don’t just serve to keep inmates in, they alsoserve to keep public eyes out.”

Alvin Bronstein, a Washington lawyer who helped found the National PrisonProject, an American Civil Liberties Union program, said he did not believethat altering the regulations risked a return to the days of Holmesburg.

“With the help of external review boards that would include a prisoneradvocate,” Mr. Bronstein said, “I do believe that the potential benefits ofbiomedical research outweigh the potential risks.”

Holmesburg closed in 1995 but was partly reopened in July to help easeovercrowding at other prisons.

Under current regulations, passed in 1978, prisoners can participate infederally financed biomedical research if the experiment poses no more than“minimal” risks to the subjects. But a report formally presented tofederal officials on Aug. 1 by the Institute of Medicine of the NationalAcademy of Sciences advised that experiments with greater risks bepermitted if they had the potential to benefit prisoners. As an addedprecaution, the report suggested that all studies be subject to anindependent review.

“The current regulations are entirely outdated and restrictive, andprisoners are being arbitrarily excluded from research that can help them,”said Ernest D. Prentice, a University of Nebraska genetics professor andthe chairman of a Health and Human Services Department committee thatrequested the study. Mr. Prentice said the regulation revision process wouldbegin at the committee’s next meeting, on Nov. 2.

The discussion comes as the biomedical industry is facing a shortage oftesting subjects. In the last two years, several pain medications, includingVioxx and Bextra, have been pulled off the market because early testing didnot include large enough numbers of patients to catch dangerous problems.

And the committee’s report comes against the backdrop of a prison populationthat has more than quadrupled, to about 2.3 million, over the last 30 yearsand that disproportionately suffers from H.I.V. and hepatitis C, diseasesthat some researchers say could be better controlled if new research werepermitted in prisons.

For Leodus Jones, a former prisoner, the report has opened old wounds. “Thismoves us back in a very bad direction,” said Mr. Jones, who participated inthe experiments at Holmesburg in 1966 and after his release played a pivotalrole in lobbying to get the regulations passed.

In one experiment, Mr. Jones’s skin changed color, and he developed rasheson his back and legs where he said lotions had been tested.

“The doctors told me at the time that something was seriously wrong,” saidMr. Jones, who added that he had never signed a consent form. He reached a$40,000 settlement in 1986 with the City of Philadelphia after he sued.

“I never had these rashes before,” he said, “but I’ve had them ever since.”

The Institute of Medicine report was initiated in 2004 when the Health andHuman Services Department asked the institute to look into the issue. Thereport said prisoners should be allowed to take part in federally financedclinical trials so long as the trials were in the later and less dangerousphase of Food and Drug Administration approval. It also recommended thatat least half the subjects in such trials be nonprisoners, making it moredifficult to test products that might scare off volunteers.

Dr. A. Bernard Ackerman, a New York dermatologist who worked at Holmesburgduring the 1960’s trials as a second-year resident from the University ofPennsylvania , said he remained skeptical. “I saw it firsthand,” Dr.Ackerman said. “What started as scientific research became pure business,and no amount of regulations can prevent that from happening again.”

Others cite similar concerns over the financial stake in such research.

“It strikes me as pretty ridiculous to start talking about prisoners gettingaccess to cutting-edge research and medications when they can’t even getpenicillin and high-blood-pressure pills,” said Paul Wright, editor ofPrison Legal News , an independent monthly review. “I have to imagine thereare larger financial motivations here.”

The demand for human test subjects has grown so much that the so-calledcontract research industry has emerged in the past decade to recruitvolunteers for pharmaceutical trials. The Tufts Center for the Study of DrugDevelopment, a Boston policy and economic research group at Tufts Universityestimated that contract research revenue grew to $7 billion in 2005, up from$1 billion in 1995.

But researchers at the Institute of Medicine said their sole focus was tosee if prisoners could benefit by changing the regulations.

The pharmaceutical industry says it was not involved. Jeff Trewitt, aspokesman for the Pharmaceutical Research and Manufacturers of America, adrug industry trade group, said that his organization had no role inprompting the study and that it had not had a chance to review the findings.

Dr. Albert M. Kligman, who directed the experiments at Holmesburg and is nowan emeritus professor of dermatology at the University of PennsylvaniaMedical School, said the regulations should never have been written in thefirst place.

“My view is that shutting the prison experiments down was a big mistake,”Dr. Kligman said.

While confirming that he used radioactive materials, hallucinogenic drugsand carcinogenic materials on prisoners, Dr. Kligman said that they werealways administered in extremely low doses and that the benefits to thepublic were overwhelming.

He cited breakthroughs like Retin A, a popular anti-acne drug, andingredients for most of the creams used to treat poison ivy. “I’m on themedical ethics committee at Penn,” he said, “and I still don’t see therehaving been anything wrong with what we were doing.”

>From 1951 to 1974, several federal agencies and more than 30 companies usedHolmesburg for experiments, mostly under the auspices of the University ofPennsylvania, which had built laboratories at the prison. After therevelations about Holmesburg, it soon became clear that other universitiesand prisons in other states were involved in similar abuses.

In October 2000, nearly 300 former inmates sued the University ofPennsylvania, Dr. Kligman, Dow Chemical and Johnson & Johnson for injuriesthey said occurred during the experiments at Holmesburg, but the suit wasdismissed because the statute of limitations had expired.

“When they put the chemicals on me, my hands swelled up like eight-ounceboxing gloves, and they’ve never gone back to normal,” said Edward Anthony,62, a former inmate who took part in Holmesburg experiments in 1964. “We’restill pushing the lawsuit because the medical bills are still coming in fora lot of us.”

Daniel S. Murphy, a professor of criminal justice at Appalachian StateUniversity in Boone, N.C., who was imprisoned for five years in the 1990’sfor growing marijuana, said that loosening the regulations would be amistake.

“Free and informed consent becomes pretty questionable when prisoners don’thold the keys to their own cells,” Professor Murphy said, “and in many casesthey can’t read, yet they are signing a document that it practically takes alaw degree to understand.”

During the Holmesburg experiments, inmates could earn up to $1,500 a monthby participating. The only other jobs were at the commissary or in the shoeand shirt factory, where wages were usually about 15 cents to 25 cents aday, Professor Hornblum of Temple said.

On the issue of compensation for inmates, the report raised concern about“undue inducements to participate in research in order to gain access tomedical care or other benefits they would not normally have.” It called for“adequate protections” to avoid “attempts to coerce or manipulateparticipation.’’

The report also expressed worry about the absence of regulation overexperiments that do not receive federal money. Lawrence O. Gostin, thechairman of the panel that conducted the study and a professor of law andpublic health at Georgetown University said he hoped to change that.

Even with current regulations, oversight of such research has beendifficult. In 2000, several universities were reprimanded for using federalmoney and conducting several hundred projects on prisoners without fullyreporting the projects to the appropriate authorities.

Professor Gostin said the report called for tightening some existingregulations by advising that all research involving prisoners be subject touniform federal oversight, even if no federal funds are involved. The reportalso said protections should extend not just to prisoners behind bars butalso to those on parole or on probation.

Professor Murphy, who testified to the panel as the report was beingwritten, praised those proposed precautions before adding, “They’re also theparts of the report that faced the strongest resistance from federalofficials, and I fear they’re most likely the parts that will end up gettingcut as these recommendations become new regulations.”Barclay Walsh contributed research for this article.

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These were not victimless crimes – illegal acts by pharmaceutical companies and false claims … can put the public health at risk, corrupt medical decisions by healthcare providers, and take billions of dollars directly out of taxpayers’ pockets.